Safety and Efficacy of DSM 32444 Postbiotic in the Treatment of Acute Rhinosinusitis

NCT05999955 | Completed DMC

• 1 other identifier: HSP32444.02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Rhinitis is a type of upper respiratory infection with a common nasal pathology especially in Southeast Asia, which is characterized by the presence of one or more of the following symptoms: itchy nose, sneezing, runny nose, and nasal congestion. Other symptoms occasionally experienced include headache, excessive pain reaction, cough, fever. Rhinitis can be idiopathic or due to a variety of causes, including allergens, medications, endocrine/metabolic, infectious, inflammatory, and abnormal nasal structures. The treatment of acute rhinosinusitis and allergic rhinitis in hospitals is currently carried out according to the general professional guidance of the Vietnam Ministry of Health. Most patients are prescribed corticosteroids, antihistamines, and antibiotics for immediate decongestion and anti-inflammatory effects. Current concerns about antimicrobial resistance (AMR) as well as side effects of corticosteroids and antihistamines have led to an urgent need for a naturebased next generation therapeutic approach that is safe, effective and helps in addressing the issues of AMR. The goal of this interventional study is to evaluate the safety and efficacy of postbiotic nasal spray using inert bioparticles of Bacillus subtilis DSM32444 in treatment of acute rhinosinusitis; and to compare the efficacy against Neomycin/Dexamethasone//Xylometazoline administered as a nasal spray as an adjunct to Amoxicillin/Clavulanate standard treatment in patients with acute rhinosinusitis. Patients with acute rhinosinusitis who give consent to participate in the study will be randomly assigned in a 1:1 ratio to one of two groups using postbiotic of Bacillus subtilis DSM32444 nasal spray ("Sperovid") or Neomycin/ Dexamethasone nasal spray for a period of 10 days. Investigators will compare whether the nasal spray using postbiotic Bacillus subtilis DSM32444 has similar efficacy as compared to Neomycin/Dexamethasone/Xylometazoline nasal spray as an adjuvant therapy along with the standard Amoxicillin/Clavulanate regimen in patients with acute rhinosinusitis based on time to improvement of rhinosinusitis symptoms.

Conditions

Rhinosinusitis; Rhinitis

Keywords

Acute Rhinosinusitis; Chronic Rhinosinusitis; Allergic Rhinosinusitis

Outcome Measures

Primary Outcomes (1)

• To compare efficacy following multiple doses of the SPEROVID Nasal Spray for 10 days with those of the Neomycin/ Dexamethasone/Xylometazoline Nasal Spray in Acute Rhinosinusitis Patients assessed by time to symptom resolution

  Time to symptom resolution based on total symptom score (TSS) TSS includes the following symptoms, each will be scored from 0 to 6: * Nasal obstruction/blockage/congestion * Discoloured nasal drainage: anterior/posterior * Headache * Fatigue * Decreased sense of smell * Ear pain/pressure/fullness * Cough * Halitosis * Dental pain * Fever Score Descriptions 0 or 1 None - to an occasional limited episode 2 or 3 Mild - Steady symptoms but easily tolerable 4 or 5 Moderately bothersome - Symptoms hard to tolerate, might interfere with activities of daily living, sleep, or both 6 Very severe - Symptoms are so bad that person cannot function virtually all the time

  Day 1 to Day 10

Secondary Outcomes (4)

• To compare safety following multiple doses of the SPEROVID Nasal Spray for 10 days with those of the Neomycin/ Dexamethasone/Xylometazoline Nasal Spray in Influenza Patients

  Day 1 to Day 10

• To compare the efficacy following multiple doses of SPEROVID Nasal Spray for 10 days with those of Neomycin/ Dexamethasone/Xylometazoline Nasal Spray in Acute Rhinosinusitis Patients assessed by time to symptom improvement

  Day 1 to Day 10

• To compare the efficacy following multiple doses of the SPEROVID Nasal Spray for 10 days with those of the Neomycin/Dexamethasone/Xylometazoline Nasal Spray in Acute Rhinosinusitis Patients assessed by Change From Baseline in Total Symptom Score (TSS)

  Day 1 to Day 10

• To compare the efficacy following multiple doses of the SPEROVID Nasal Spray for 10 days with those of the Neomycin/Dexamethasone/Xylometazoline Nasal Spray in Acute Rhinosinusitis Patients assessed by Clinical Failure Rate at the End of Treatment

  Day 1 to Day 10

Study Arms (2)

Control

ACTIVE COMPARATOR

Subjects in Control group receive Neomycin Nasal Spray for 10 days.

Drug: Neomycin/ Dexameythasone/Xylometazoline

SPEROVID

EXPERIMENTAL

Subjects in Experimental group receive a nasal spray containing Bacillus subtilis DSM32444 ("Sperovid") for 10 days.

Combination Product: Bacillus subtilis DSM32444

Interventions

Neomycin/ Dexameythasone/Xylometazoline DRUG

The active-control in the phase II study was a commercial form of nasal spray containing Dexamethasone/Neomycin/Xylometazoline. This formulation is approved by Vietnam's Ministry of Health as a treatment regime for rhinosinusitis. Dexamethasone sodium phosphate is fluoromethyl prednisolone, a synthetic glucocorticoid. Dexamethasone has the main effects of glucocorticoids as anti-inflammatory, antiallergic and immunosuppressant. Neomycin sulfate is an antibiotic belonging to the group of aminoglycosides that have a bactericidal mechanism due to inhibition of bacterial protein biosynthesis. In this study, the nasal spray is used as an adjunct to Amoxicillin/Clavulanate standard treatment

Control

Bacillus subtilis DSM32444 COMBINATION_PRODUCT

Postbiotic DSM32444 is manufactured by HURO BIOTECH Company as a drug-grade active pharmaceutical ingredient. The Class A medical device containing Postbiotic DSM32444 is called Sperovid, which is manufactured by Dong Duoc Viet under ISO 13485:2016 standards for medical device. Sperovid has registration number: 220000033/ PCBALA In this study, the nasal spray is used as an adjunct to Amoxicillin/Clavulanate standard treatmen.

Also known as: Sperovid, Speromed, Sperokid, inactivated DSM32444

SPEROVID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed rhinosinusitis patients (according to Vietnam's MOH guidelines for diagnosis of rhinosinusitis), ≥18 years of age, at the time of signing the informed consent.
• Must be in generally good health, except rhinosinusitis
• Patients who are able to use an e-Diary or Paper Diary during the study to report their health status
• Patients capable of giving a signed informed consent form (ICF)

You may not qualify if:

• Presence of any nasal mucosal erosion, nasal ulceration, or nasal septal perforation (Grade 1b - 4)
• Other nasal disease(s) likely to affect deposition of intranasal medication, such as sinusitis, rhinitis medicamentosa, clinically significant polyposis, or nasal structural abnormalities.
• Nasal surgery or sinus surgery within the previous year
• Chronic sinusitis - more than 3 episodes per year
• Asthma (with the exception of mild, intermittent asthma). Subjects with mild, intermittent asthma who only require short-acting inhaled bronchodilators (not more often than twice per week) and who do not have nocturnal awakening as a result of asthma are eligible for enrolment.
• Planned travel outside of the study area during the study period.
• Use of any investigational drug within 30 days prior to Day screening. No investigational products are permitted for use during the conduct of this study.
• Existence of any medical condition, which in the opinion of the investigator, might significantly affect the subject's ability to complete this trial; or their safety in this trial.

Sponsors & Collaborators

• Huro Biotech Joint Stock Company: lead
• Vietstar Biomedical Research: collaborator

Study Sites (1)

Thai Binh University of Medicine and Pharmacy

Thái Bình, Thai Binh, Vietnam

Location

Related Publications (6)

• James J, Meyer SM, Hong HA, Dang C, Linh HTY, Ferreira W, Katsande PM, Vo L, Hynes D, Love W, Banyard AC, Cutting SM. Intranasal Treatment of Ferrets with Inert Bacterial Spores Reduces Disease Caused by a Challenging H7N9 Avian Influenza Virus. Vaccines (Basel). 2022 Sep 19;10(9):1559. doi: 10.3390/vaccines10091559.

  PMID: 36146637 BACKGROUND

• de Souza RD, Batista MT, Luiz WB, Cavalcante RC, Amorim JH, Bizerra RS, Martins EG, Ferreira LC. Bacillus subtilis spores as vaccine adjuvants: further insights into the mechanisms of action. PLoS One. 2014 Jan 27;9(1):e87454. doi: 10.1371/journal.pone.0087454. eCollection 2014.

  PMID: 24475289 BACKGROUND

• Huang JM, La Ragione RM, Nunez A, Cutting SM. Immunostimulatory activity of Bacillus spores. FEMS Immunol Med Microbiol. 2008 Jul;53(2):195-203. doi: 10.1111/j.1574-695X.2008.00415.x. Epub 2008 Apr 21.

  PMID: 18430003 BACKGROUND

• Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, Lang DM, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph CC, Schuller D, Spector SL, Tilles SA; Joint Task Force on Practice; American Academy of Allergy; Asthma & Immunology; American College of Allergy; Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol. 2008 Aug;122(2 Suppl):S1-84. doi: 10.1016/j.jaci.2008.06.003. No abstract available.

  PMID: 18662584 BACKGROUND

• Baraniuk JN. Pathogenic mechanisms of idiopathic nonallergic rhinitis. World Allergy Organ J. 2009 Jun 15;2(6):106-14. doi: 10.1097/WOX.0b013e3181aadb16.

  PMID: 24229057 BACKGROUND

• Bousquet J, Khaltaev N, Cruz AA, Denburg J, Fokkens WJ, Togias A, Zuberbier T, Baena-Cagnani CE, Canonica GW, van Weel C, Agache I, Ait-Khaled N, Bachert C, Blaiss MS, Bonini S, Boulet LP, Bousquet PJ, Camargos P, Carlsen KH, Chen Y, Custovic A, Dahl R, Demoly P, Douagui H, Durham SR, van Wijk RG, Kalayci O, Kaliner MA, Kim YY, Kowalski ML, Kuna P, Le LT, Lemiere C, Li J, Lockey RF, Mavale-Manuel S, Meltzer EO, Mohammad Y, Mullol J, Naclerio R, O'Hehir RE, Ohta K, Ouedraogo S, Palkonen S, Papadopoulos N, Passalacqua G, Pawankar R, Popov TA, Rabe KF, Rosado-Pinto J, Scadding GK, Simons FE, Toskala E, Valovirta E, van Cauwenberge P, Wang DY, Wickman M, Yawn BP, Yorgancioglu A, Yusuf OM, Zar H, Annesi-Maesano I, Bateman ED, Ben Kheder A, Boakye DA, Bouchard J, Burney P, Busse WW, Chan-Yeung M, Chavannes NH, Chuchalin A, Dolen WK, Emuzyte R, Grouse L, Humbert M, Jackson C, Johnston SL, Keith PK, Kemp JP, Klossek JM, Larenas-Linnemann D, Lipworth B, Malo JL, Marshall GD, Naspitz C, Nekam K, Niggemann B, Nizankowska-Mogilnicka E, Okamoto Y, Orru MP, Potter P, Price D, Stoloff SW, Vandenplas O, Viegi G, Williams D; World Health Organization; GA(2)LEN; AllerGen. Allergic Rhinitis and its Impact on Asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy. 2008 Apr;63 Suppl 86:8-160. doi: 10.1111/j.1398-9995.2007.01620.x. No abstract available.

  PMID: 18331513 BACKGROUND

MeSH Terms

Conditions

Rhinosinusitis; Rhinitis; Rhinitis, Allergic, Perennial

Interventions

Neomycin; xylometazoline

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Sinusitis; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Rhinitis, Allergic; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Kien T NGUYEN, PhD

  Thai Binh University of Medicine and Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: December 29, 2022
• Primary Completion: April 27, 2023
• Study Completion: May 25, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)